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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK DRYDOC STATION; DRY DOC
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C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK DRYDOC STATION; DRY DOC Back to Search Results
Catalog Number DD15
Device Problems Labelling, Instructions for Use or Training Problem (1318); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the patient and her daughter stated that they have requested a purewick drydoc manual several times and still have not received one.The daughter is very upset and unhappy.Per follow up call on 3dec2019, the customer stated they never received the manual for their dry doc.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.The potential root cause could be due to " operator error - incorrect packaging." the lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not completed as the user would not likely cause this issue.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the patient and her daughter stated that they have requested a purewick drydoc manual several times and still have not received one.The daughter is very upset and unhappy.Per follow up call on 3dec2019, the customer stated they never received the manual for their dry doc.
 
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Brand Name
PUREWICK DRYDOC STATION
Type of Device
DRY DOC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9474614
MDR Text Key178772115
Report Number1018233-2019-07986
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741151781
UDI-Public(01)00801741151781
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberDD15
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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